Implementation of a biobank infrastructure to facilitate development and improvement of screening markers for colorectal neoplasia. New biomarkers will be compared to state of the art tests, e.g. currently FIT.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Collection of faeces for development and improvement of new biomarkers for CRC.
Development of a stool test with a (panel of) molecular marker(s).
Endpoints for evaluation of screening markers: presence of CRC and advanced
adenomas (advanced neoplasia).
The following test characteristics are used as primary outcome measurements for
the different biomarkers.
- Sensitivity
- Specificity
- Positive predictive value (PPV)
- Negative predictive value (NPV)
Secondary outcome
Quality and stability of samples collected.
Background summary
Colorectal cancer (CRC) is one of the three malignancies with highest incidence
and mortality in the industrialized world. Population based screening is likely
to be the most effective strategy to decrease CRC related mortality. Screening
by guaiac-based faecal occult blood tests (g-FOBT) has shown to decrease CRC
related mortality. Even though faecal immunochemical tests (FITs) have shown
superior performance over g-FOBTs, test performance is still suboptimal.
Previous studies on detection of exfoliated tumour specific (methylated) DNA
and proteins in faeces showed promising results. However, translation of such
findings from basic research towards daily practice is hampered by a limited
sample size and lack of prospective study design.
Study objective
Implementation of a biobank infrastructure to facilitate development and
improvement of screening markers for colorectal neoplasia. New biomarkers will
be compared to state of the art tests, e.g. currently FIT.
Study design
Prospective cohort study.
Study burden and risks
Burden for participant contains at home faeces collection.
De Boelelaan 1118
1007 MB Amsterdam
NL
De Boelelaan 1118
1007 MB Amsterdam
NL
Listed location countries
Age
Inclusion criteria
All subjects 40 years of age or older scheduled for colonoscopy will be invited to participate. Subjects with colorectalcancer (CRC) or advanced adenomas detected at colonoscopy will be included as cases, whereas subjects without advanced neoplasia will be included as controls.
All subjects should be capable to give informed consent. All subjects should speak and understand the Dutch language
Exclusion criteria
- Subjects < 40 years of age
- No informed consent
- Subjects with IBD/sigmoidoscopy or colonoscopy in the past four weeks/extended hemicolectomie/colostomy
- Subjects who received chemotherapy in the past three weeks
- Hospitalized individuals
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL38872.094.11 |